Study of RMC-6291 with ivonescimab drug combination in patients with advanced RAS‑mutated solid tumors

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What is this study about?

The study focuses on patients with Solid Tumors that have a change called RAS‑mutated. The investigational medicines being tested include an intravenous antibody named ivonescimab and a group of oral drugs referred to as RAS(ON) inhibitors. Specific pills that may be used are RMC‑6291, DARAXONRASIB (RMC‑6236) and RMC‑9805. These agents can also be given together with standard chemotherapy drugs such as cisplatin.

The purpose of the study is to evaluate safety and find the best dose of the new medicines when used alone or in combination. Participants receive an IV infusion, which means the medicine is delivered directly into a vein, and they swallow tablets on a regular schedule. Treatment cycles are repeated every few weeks, and patients return to the clinic for regular check‑ups, blood tests, and simple examinations to watch for any side effects.

1 baseline assessments

after joining the study, initial examinations are performed to record medical history, current health status, and laboratory test results.

imaging studies are done to document the size and location of solid tumors before any treatment is given.

2 first administration of ivonescimab

the patient receives ivonescimab by intravenous infusion. the specific dose, frequency, and duration are defined in the study protocol but are not detailed in the provided information.

the infusion is given in a clinical setting where vital signs are monitored during and after the procedure.

3 administration of additional anti‑cancer agents

depending on the study arm, the patient may also receive one or more of the following agents:

erbitux 5 mg/ml solution for infusion (contains cetuximab) given by infusion;

cisplatin hikma 1 mg/ml solution for infusion;

carboplatin kabi 10 mg/ml solution for infusion;

pemetrexed 25 mg/ml concentrate for infusion.

each medication is administered by infusion according to the schedule defined by the trial, which is not specified in the source data.

4 oral tablet therapy

the patient takes oral tablets that are part of the study regimen:

rmc‑6291 tablet;

daraxonrasib (rmc‑6236) tablet;

rmc‑9805 tablet.

the exact dose, how many times per day, and the total length of treatment are determined by the protocol but are not provided in the source information.

5 regular safety monitoring

throughout the trial, the patient undergoes repeated laboratory tests, including blood counts and chemistry panels, to detect any adverse effects.

vital signs such as blood pressure, heart rate, and temperature are checked at each visit.

any side effects, serious adverse events, or dose‑limiting toxicities are recorded according to the study’s safety objectives.

6 tumor response evaluation

periodic imaging (for example, CT or MRI scans) is performed to assess changes in tumor size.

the results are compared with baseline images to determine response according to RECIST v1.1 criteria, which classify outcomes such as partial response, stable disease, or progression.

7 continuation or discontinuation of treatment

treatment cycles are repeated as long as the patient meets eligibility criteria and does not experience unacceptable toxicity.

the study may end for the patient when the predefined treatment period is completed, when disease progression occurs, or when the patient chooses to stop therapy.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must have a cancer that carries a RAS mutation, and the cancer must be advanced (it has spread or cannot be removed by surgery).
  • You must have at least one tumor that doctors can see and measure on imaging scans (a measurable tumor).
  • If a part of the study requires a particular type of RAS mutation, you must have that specific mutation.
  • You must have adequate organ function, meaning your heart, liver, kidneys and other vital organs work well enough for the treatment.

Who Cannot Join the Study?

  • Cannot have taken medicines that directly target RAS, or certain immune or anti-VEGF therapies (drugs that block a signal that helps tumors grow new blood vessels).
  • Cannot have any medical condition such as a bleeding problem or an active infection that could interfere with the study drug.
  • Cannot be pregnant or breastfeeding.
  • May be excluded if you have already received cancer treatment when the specific part of the study does not allow prior treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Karolinska University Hospital Solna Sweden
Centre hospitalier universitaire de Liege Liege Belgium
Vrije Universiteit Brussel Jette Belgium
Az Maria Middelares Gent Gent Belgium
Metropolitan Hospital Athens Greece
Region Gaevleborg Gavle Sweden
Centre Francois Baclesse Caen France
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Santa Maria Della Misericordia Perugia Italy
Universita Degli Studi Di Brescia Brescia Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Hm Nou Delfos Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Asiirr Mqbubgq Cnawgy Slmq Thessaloniki Greece
Ulifbzlzaj Os Ablizgu Edegem Belgium
Ihdwjilo Rcxsrpoe Dy Cwezlz Dm Mctzjhyfilm Montpellier France
Igsmhbyw Rjwrbgdhs Ptg Lq Sstnmq Dcl Tjfzth Dlfa Akbtpta Iebs Sruqen Meldola Italy
Akmwkrvlaf Pbpxkwzw Hojofuzf Dl Mfccfrqli Marseille France
Adgpcln Okbmidfxpdp Uueskrwzrukrl Saqrey Siena Italy
Gcwpbp Urmtlrfraq Fslyhzjbl Frankfurt Germany
Cebjzy Likd Bjhvwp Lyon France
Ixfvap Ixwolldx Fshkduzxsteik Oljahpkixep Rome Italy
Htideogm Vsue dliaosco Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.07.2026
France France
Not yet recruiting
15.07.2026
Germany Germany
Not yet recruiting
15.07.2026
Greece Greece
Not yet recruiting
15.07.2026
Italy Italy
Not yet recruiting
15.07.2026
Spain Spain
Not yet recruiting
15.07.2026
Sweden Sweden
Not yet recruiting
15.07.2026

Trial locations

Ivonescimab is an experimental drug given by IV infusion. It is a type of antibody that is being studied to see if it can help the immune system recognize and attack cancer cells. In this trial it is combined with other medicines to test its safety and how well it works.

Cetuximab (sold as Erbitux) is an approved medicine that blocks a protein called EGFR on cancer cells. By stopping EGFR, it can slow the growth of some tumors. In the study it is used together with ivonescimab to see if the two drugs work better together.

Cisplatin is a chemotherapy drug given through an IV solution. It works by damaging the DNA of cancer cells, which can stop them from growing. In this trial it may be added to the combination of ivonescimab and other agents to see how the mix is tolerated.

Carboplatin is another chemotherapy medicine delivered by IV infusion. Like cisplatin, it interferes with the DNA of cancer cells to stop their growth. It is being tested in combination with ivonescimab and other study drugs.

Pemetrexed is a chemotherapy drug that is given as an IV infusion. It stops cancer cells from making the building blocks they need to multiply. In the trial it may be used alongside ivonescimab and other treatments.

RMC-6291 is an oral, experimental medication that targets the active form of the RAS protein inside cancer cells. By blocking this protein, the drug aims to stop tumor growth. The study is looking at how safe it is and what dose works best when combined with ivonescimab.

RMC-6236 (also called DARAXONRASIB) is an oral investigational drug designed to inhibit the “ON” state of the RAS protein, which drives many cancers. It is being tested with ivonescimab to find a safe dose and see if the combination can control tumor growth.

RMC-9805 is an oral experimental therapy whose exact mechanism is being studied. It is included in the trial to evaluate its safety and potential benefit when given with ivonescimab and possibly other anti‑cancer agents.

Solid tumor – A solid tumor is an abnormal mass of tissue that forms when cells grow uncontrollably. These growths develop in organs or tissues such as the breast, lung, colon, or bone and remain localized at first. Over time, they can enlarge and may invade nearby structures, spreading into surrounding tissues. As they grow, they can acquire additional changes that allow them to spread to distant parts of the body.

Trial ID:
2025-524623-50-00
Protocol code:
RMC-APEX-103
NCT ID:
NCT07397338
Trial Phase:
Human Pharmacology (Phase I) – Other

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